Merlin™

Basic Information

• Brand Name: Merlin™
• Primary DI: 05414734500661
• Version / Model: 3650
• Catalog Number: 3650
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-30
• Public Version: 6
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: 690d1bbb-b8f9-44a0-b441-6f9e2346ed32

Device Description

Patient Care System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61393	Multiple active implantable device programmer	An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734500661	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).